This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .
Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, will be increased in the first 4 weeks to a maximum of 30 mg/day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
All patients will receive open-label single oral acitretin 10 mg capsule once daily as a starting dose. If well tolerated, the dose will be increased in the first 4 weeks to a maximum of 30mg/day. Patients will be instructed to take the treatment as a single oral dose with a meal.
Windsor Clinical Research Inc.
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy.
Time frame: 12-24 weeks
Proportion of patients who reach a partial response defined as a PGA of clear, almost clear or mild at the end of therapy
Time frame: 12-24 weeks
Change from baseline in modified Total Lesion Symptom Score (mTLSS) at the end of therapy
Time frame: 12-24 weeks
Mean time to response defined as the number of days between baseline and the time the patient reaches a PGA of clear or almost clear
Time frame: 24 weeks
Mean Patient Global Assessment (PaGA) at the end of therapy
Time frame: 12-24 weeks
Change from baseline in extent of disease at the end of therapy
Time frame: 12-24 weeks
Type, severity and relationship of adverse events
Time frame: 12-24 weeks
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